Catalog Number

47260025

Brand Name

BD Safety-Lok™ Infusion Set with Filter

Version/Model Number

47260025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033350,K033350,K033350

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

108bf03d-7bf6-4b13-a478-e9af7d330442

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

30382904726004

Quantity per Package

50

Contains DI Package

00382904726003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack